Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (no GLP)

Data source

Reference
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
97% Ethyl-2 cyanoacrylate

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 g ethyl cyanoacrylate
Duration of treatment / exposure:
24 hours
Observation period:
The test areas were scored for dermal irritation immediately following the 24-hour exposure period and again at 72 hours.
Number of animals:
six male rabbits
Details on study design:
The skin on the dorsal surface of six male albino rabbits of theNew Zealand strain was shaved free of hair with an electric clipper. Twelve dorsal test areas were utilized; six of the dorsal test areas were abraded down to, but not through, the dermis, using a hypodermic needle. The reamining test areas were left intact. Standard patch test plasters (1" x 1" gauze pad) were saturated with 0,5g ethyl cyanoacrylat and applied to the dermal test areas. The patch test plasters were left in place for 24 hours. The test areas were scored for dermal irritation immediately following in the 24-hour expossure period and again at 72 hours.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
0.87

Any other information on results incl. tables

 

Time of Observation [Hours]

Response Rabbit No.

Mean Score

 

 

1

2

3

4

5

6

 

Erythema & Eschar:

 

 

 

 

 

 

 

 

Intact Skin

24

2

2

1

1

1

2

1.50

Intact Skin

72

0

0

0

0

0

1

0.16

Abraded Skin

24

2

2

1

1

1

2

1.50

Abraded Skin

72

0

1

0

0

0

1

0.33

 

 

 

 

 

 

Subtotal:

3.49

Edema Foramtion:

 

 

 

 

 

 

 

 

Intact Skin

24

2

2

1

1

1

2

1.50

Intact Skin

72

0

0

0

0

0

1

0.16

Abraded Skin

24

2

2

1

1

1

2

1.50

Abraded Skin

72

0

1

0

0

0

1

0.33

 

 

 

 

 

 

Subtotal:

3.49

 

 

 

 

 

 

Total:

6.98

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
The aim of this study was to investigate possible reversible or irreversible irritancy and/or corrosion by the test substance following a single
application to the intact skin of rabbits.
Methods and investigations were performed in conformance with the OECD Guideline 404.
A slightly skin irritation was observed.
Executive summary:

Aim of study

The aim of this study was to investigate possible reversible or irreversible irritancy and/or corrosion by the test substance following a single application to the intact skin of rabbits.

Methods

Methods and investigations were performed in conformance with the OECD Guideline 404.

Administration of the test substance

0.5 g ethyl-2-cyanoacrylate was applied to intact skin areas and to abraded skin areas (covered with an gauze bandage) of each of 6 rabbits. The duration of the exposure was 24 hours.

Investigations

Skin examination: after the 24-hour exposure and 72 hours after patch removal.

Results

The primary dermal irritation index (PDII) was found to be 0.87

A slightly skin irritation was observed.